Postoperative Sleep DisturbancePhase 2NCT07811401

Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery

A Phase 2 study testing Lemborexant 5 mg in people with Postoperative Sleep Disturbance and Thoracoscopic Surgery, run by Beijing Tiantan Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Postoperative Sleep Disturbance, Thoracoscopic Surgery
What is being tested?: Lemborexant 5 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 130 participants
Where: No sites listed yet
Study dates: 8 Oct 2026to 1 Jun 2028
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged between 18 and 70 years;
ASA I-III;
Patients scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) under general anaesthesia, including wedge resection, segmentectomy and lobectomy;
Pre-operative Pittsburgh Sleep Quality Index (PSQI) score > 5 points;
Expected post-operative hospital stay of ≥3 days;
Signing of a written informed consent form.

Who cannot join

Patients whose surgery is expected to finish after 19:00, or who will remain intubated post-operatively or require admission to the ICU;
Patients with a pre-operative diagnosis of moderate to severe obstructive sleep apnoea (OSA);
Patients who take sedatives, sleeping tablets or antidepressants on a long-term basis;
Patients with moderate to severe hepatic or renal impairment;
Patients with cognitive impairment preventing them from cooperating with scale-based assessments;
Patients with pre-existing chronic neuropathic pain;
Patients unsuitable for or refusing to participate in this study for other. reasons.

About this study

Official title: The Effect of Lemborexant on Perioperative Sleep Quality in Patients Undergoing Thoracoscopic Surgery: A Randomized Controlled Trial

Video-assisted thoracoscopic surgery (VATS) is the mainstream minimally invasive procedure in thoracic surgery; However, the high-stress state during the perioperative period and severe postoperative pain often lead to significant disruption of patients' sleep patterns, thereby exacerbating postoperative pain sensitisation and delaying early recovery. Traditional sleep-inducing drugs, primarily benzodiazepines, have significant limitations in the perioperative period of thoracic surgery, including respiratory depression, dizziness and residual central effects, which hinder early ambulation. As a new-generation dual orexin receptor antagonist, Lemborexant exerts its sleep-promoting and anti-stress effects by precisely blocking excessive arousal pathways. Furthermore, it causes no respiratory depression, no hangover-like effects the following day, and does not impair muscle strength or mucus clearance, offering the potential to meet the dual requirements of sleep quality and high safety in Enhanced Recovery After Surgery (ERAS) protocols for thoracic surgery. However, there remains a lack of prospective clinical evidence regarding its application in the high-stress, high-pain perioperative acute cohort of thoracoscopic surgery. This study aims to conduct a prospective, randomised, double-blind, placebo-controlled clinical trial to improve perioperative sleep quality in VATS patients. The primary outcome measure of the study was the difference in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total Richards-Campbell Sleep Questionnaire (RCSQ) score on the night of surgery. The study aims to investigate the causal relationship between short-term perioperative Lemborexant intervention and improvements in patient sleep and postoperative recovery quality. The anticipated results will provide clinical evidence of the safety and efficacy of Lemborexant for use in high-stress populations during the perioperative period.

Conditions: Postoperative Sleep Disturbance, Thoracoscopic Surgery
Being tested: Lemborexant 5 mg, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lemborexant 5 mgDrug
The intervention group will take Lemborexant tablets three times during the perioperative period
PlaceboDrug
The control group will take placebo tablets with the same appearance, smell and properties as the intervention group three times during the perioperative period

Study groups in NCT07811401
Study group	Role	What they receive
lemborexant	Experimental	the intervention group Receives: Drug: Lemborexant 5 mg
placebo	Placebo comparator	the control group Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of postoperative sleep disturbance (PSD)
Differences in the incidence of perioperative sleep disorders (PSD) between the two groups, as assessed by the total score on the Richards-Campbell Sleep Questionnaire (RCSQ). The scale comprises five core items evaluating distinct sleep domains: sleep depth, sleep latency, frequency of awakenings, ability to return to sleep, and overall sleep quality. Each item is rated on a 100-mm visual analogue scale (VAS). The total score is calculated as the mean of the five core item scores, yielding a range from 0 to 100. A higher total score indicates better perceived sleep quality. Specifically, a score of 0 represents the worst possible sleep, while a score of 100 represents the best possible sleep.
Measured: The first night after the operation

Secondary outcomes (3)

Objective sleep quality
Total sleep time (TST) and wake time after sleep onset (WASO) as monitored by the Huawei sleep tracker.
Measured: From the night before surgery to the second night after surgery (three consecutive nights).
Postoperative pain scores
Resting pain (NRS-R) and movement-induced pain (NRS-C) at 24 and 48 hours postoperation. Assessment was carried out using a numerical rating scale for pain intensity.
Measured: At 24 and 48 hours postoperation
Postoperative anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) was used to assess changes in perioperative anxiety and depression subscale scores compared with baseline values.
Measured: The day before the operation and on the third day after the operation, or upon discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 20261 Jun 2028

First posted10 Sep 2026
Study start8 Oct 2026 (estimated)
Primary completion31 Dec 2027 (estimated)
Study completion1 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Postoperative Sleep DisturbanceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 130 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07811401
Sponsor's protocol ID: LV-20260903
Status last verified: Oct 2026
First submitted: 3 Sep 2026
Last updated: 20 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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